Combined Qigong and Acupressure for Improving Chemotherapy-induced Peripheral Neuropathy

NCT ID: NCT05764447

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-10
• Study Completion Date: 2025-03-31

Brief Summary

The objective of the study is to investigate the effects of a 16-week combined qigong and acupressure intervention on reducing self-reported chemotherapy-induced peripheral neuropathy (CIPN) severity, objective measures of CIPN severity, lower-extremity functioning, handgrip strength, fall incidence, and health-related quality of life post-intervention among post-chemotherapy adult cancer patients. This will be a 2-arm assessor-blinded randomized controlled trial that will follow the CONSORT guidelines. A total of 104 cancer patients aged ≥18 who have completed neurotoxic chemotherapy at least 1 month prior to enrolment and experiencing CIPN will be recruited and randomized into combined qigong and self-administered acupressure intervention and wait-list control groups. The intervention group comprises of twice-weekly supervised group sessions and three times-weekly self-practice prescription (30 min each time) on days without group sessions. The control group will be offered a free modality of their choice after the last follow-up. The participants will receive usual care alone during the study period.

Detailed Description

Chemotherapy-induced peripheral neuropathy (CIPN) is one of the most common side effects of chemotherapy experiencing by cancer patients. CIPN can lead to significant distress, diminished health-related quality of life, functional decline, and an increased risk of falls in cancer patients, as they may experience altered proprioception. CIPN may continue to progress for several months post-treatment or even persist for years following chemotherapy.

Current pharmacological approaches are limited not only by side effects (e.g., fatigue, dizziness, insomnia, or nausea) but also by patients' unwillingness to further medicate a drug-related side effect. Also, the drugs may treat pain but not non-painful CIPN symptoms, and cannot induce neuro-protection or neuro-regeneration. Non-pharmacological interventions may be more appealing to patients, as they usually have no side effects and may result in clinical benefits for CIPN sufferers.

Acupressure is a non-invasive variant of acupuncture both adopting the meridian theory of traditional Chinese medicine (TCM) that stimulate acupoints across meridians and facilitate the flow of qi (energy) and blood, thereby restoring health and treating disease. Qigong is a mind-body exercise also rooted in the meridian theory of TCM. Through a combination of movement, breath control, and meditation, meridians can be opened, and the flow of qi and blood stimulated, to restore health. The combination approach is likely to elicit complementary physiologic adaptations on mechanisms involving both the peripheral and central nervous systems, thereby inducing a larger and potentially clinically meaningful improvement on CIPN.

Conditions

Cancer; Chemotherapy-induced Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Combined Qigong Baduanjin and Self-administered Acupressure Intervention

The intervention will last 16 weeks, including twice-weekly supervised group sessions. The first 8 weeks will focus on training of qigong Baduanjin and self-administered acupressure. The duration of each group session will be 90 min. From week 9 onwards, the group sessions will be shortened to 60 min twice a week led by the BQ master. For self-practice prescription, participants will be instructed to practice the combined BQ and acupressure intervention three times a week (30 min each time) on the days without group sessions.

Group Type: EXPERIMENTAL

Combined qigong Baduanjin and self-administered acupressure

Intervention Type: BEHAVIORAL

The intervention will combine Baduanjin (BQ) and acupressure. The general design of the combination intervention is for BQ to be performed first (20 min), followed by self-administered acupressure (10 min). BQ comprises eight simple standardized movements. The combination of these simple body movements, breath control, and mindful meditation is designed to improve qi function.The acupressure protocol comprises six acupoints, i.e., Hegu, Quchi, Zusanli, Sanyinjiao, Qihai, and Taichong, which are the most commonly used acupoints in acupuncture trials for relieving CIPN according to previous reviews. These acupoints, based on TCM theory, are beneficial for strengthening the origin of qi and directing its flow to the upper and lower extremities. A massage pen will be used to stimulate the acupoints because participants with CIPN may have difficulty applying pressure with their hands/fingers.

Wait-list Control Group

The control group will be offered a free modality of their choice after the last follow-up. The participants will receive usual care alone during the study period.

Group Type: ACTIVE_COMPARATOR

Wait-list Control

Intervention Type: BEHAVIORAL

The participants will receive usual care alone during the study period and will be offered the training after the last follow-up.

Interventions

Combined qigong Baduanjin and self-administered acupressure

The intervention will combine Baduanjin (BQ) and acupressure. The general design of the combination intervention is for BQ to be performed first (20 min), followed by self-administered acupressure (10 min). BQ comprises eight simple standardized movements. The combination of these simple body movements, breath control, and mindful meditation is designed to improve qi function.The acupressure protocol comprises six acupoints, i.e., Hegu, Quchi, Zusanli, Sanyinjiao, Qihai, and Taichong, which are the most commonly used acupoints in acupuncture trials for relieving CIPN according to previous reviews. These acupoints, based on TCM theory, are beneficial for strengthening the origin of qi and directing its flow to the upper and lower extremities. A massage pen will be used to stimulate the acupoints because participants with CIPN may have difficulty applying pressure with their hands/fingers.

Intervention Type: BEHAVIORAL

Wait-list Control

The participants will receive usual care alone during the study period and will be offered the training after the last follow-up.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥18 years
• diagnosis of cancer
• completed neurotoxic chemotherapy at least 1 month prior to enrolment
• experiencing CIPN (defined as tingling, numbness, or pain in the extremities in the past week, on the basis of a score ≥4 on an 11-point numerical rating scale due to receiving neurotoxic chemotherapy)
• Eastern Cooperative Oncology Group performance status between 0 and 2
• able to communicate in Cantonese or Mandarin

Exclusion Criteria

• they have psychiatric disorders or conditions that preclude practicing qigong or acupressure (e.g., recent myocardial infarction, breathing difficulties requiring oxygen use or hospitalization, cannot walk independently)
• have regularly engaged in qigong or acupressure (>once per week) in the previous 6 months
• are receiving acupuncture
• are pregnant or lactating
• have any infection/injury/ulcers around the acupoints, or had peripheral neuropathy before chemotherapy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Cheung Shuk-Ting

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Countries

Hong Kong

Other Identifiers

UW22587

Identifier Type: -

Identifier Source: org_study_id